eligibility_summary
Adults 18–80, ECOG 0–1, histologic/cytologic LA/m urothelial cancer, ≥1 prior systemic therapy or untreated, measurable per RECIST 1.1, tumor tissue, adequate organs, life expectancy ≥12 wks, contraception. Exclude recent chemo/radiation (<21d) or major surgery (<28d), prior PD-(L)1 or MMAE-ADC, ≥G2 toxicity/neuropathy, uncontrolled DM/infections/CNS mets/serious disease, cardiac/cerebrovascular/corneal risk, strong P‑gp/CYP3A4 drugs, autoimmune tx, recent vaccines/investigational drugs, recent other malignancy, allergy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial tests 9MW2821 plus toripalimab in advanced/metastatic urothelial cancer. 9MW2821 is an antibody–drug conjugate (ADC) targeting Nectin‑4 on tumor cells, after binding and internalization it releases the MMAE cytotoxic payload, a microtubule inhibitor that disrupts tubulin polymerization and induces apoptosis (with potential bystander and ADCC effects). Toripalimab is a human IgG4 monoclonal antibody immune checkpoint inhibitor that blocks PD‑1 to restore and amplify T‑cell antitumor activity. Targets/pathways: Nectin‑4–expressing urothelial tumor cells, microtubule dynamics, PD‑1/PD‑L1 immune checkpoint on T cells.